JWHFDA Class 2 · 21 CFR 888.3560 · implantable
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device family · Orthopedic
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
910
Manufacturers
69
Flagged signals
17
Adverse-event reports
142,227
Code matrix
| FDA product code | JWH |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 174 | 33.2 | 5,388 |
| Other | 2012 | 154 | 29.4 | 4,183 |
| Other | 2011 | 152 | 29.0 | 4,071 |
| Other | 2013 | 112 | 21.4 | 2,148 |
| Other | 2015 | 4 | 21.3 | 58 |
| Other | 2010 | 3 | 14.6 | 26 |
| Death | 2012 | 3 | 11.0 | 18 |
| Other | 2010 | 10 | 10.6 | 78 |
| Other | 2010 | 8 | 9.9 | 56 |
| Other | 2009 | 7 | 7.4 | 33 |
| Other | 2013 | 83 | 5.0 | 260 |
| Other | 2014 | 26 | 4.9 | 78 |
| Injury | 2013 | 16 | 2.6 | 23 |
| Injury | 2017 | 7 | 2.6 | 9 |
| Injury | 2011 | 4 | 2.6 | 4 |
| Injury | 2016 | 4 | 2.6 | 4 |
| Injury | 2011 | 16 | 2.2 | 15 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 142,227 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Zimmer, Inc. | 51 | 2025 | — |
| Smith & Nephew, Inc. | 49 | 2025 | — |
| Howmedica Corp. | 47 | 1998 | — |
| Conformis, Inc. | 40 | 2023 | — |
| Biomet, Inc. | 40 | 2017 | — |
| Exactech, Inc. | 32 | 2023 | — |
| Depuy, Inc. | 31 | 2004 | — |
| Howmedica Osteonics Corp. | 30 | 2013 | — |
| Dow Corning Wright | 24 | 1994 | — |
| Osteonics Corp. | 24 | 1998 | — |
| Wrightmedicaltechnologyinc | 20 | 2013 | — |
| Orthomet, Inc. | 19 | 1994 | — |
| Intermedics Orthopedics | 19 | 1997 | — |
| Medacta International S.A. | 17 | 2023 | — |
| Implex Corp. | 17 | 2004 | — |
| Encore Medical L.P. | 15 | 2025 | — |
| DEPUY ORTHOPAEDICS, INC. | 15 | 2020 | — |
| MAXX ORTHOPEDICS, INC. | 14 | 2025 | — |
| Johnson & Johnson Professionals, Inc. | 14 | 1997 | — |
| United Orthopedic Corporation | 13 | 2025 | — |
| Materialise NV | 13 | 2026 | — |
| TOTAL JOINT ORTHOPEDICS, INC. | 12 | 2022 | — |
| CORENTEC CO., LTD. | 12 | 2025 | — |
| Encore Orthopedics, Inc. | 11 | 2002 | — |
| Medacta International | 10 | 2014 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Materialise TKA Guide System · Materialise NV510(k) · 2026-01-06
EMPOWR Knee · Encore Medical L.P.510(k) · 2025-12-19
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors · Depuy Ireland UC510(k) · 2025-11-19
Freedom Infinia Total Knee System · Maxx Orthopedics, Inc.510(k) · 2025-10-29
Freedom® Total Knee System Titan PCK Components · Maxx Orthopedics, Inc.510(k) · 2025-10-22
Stem Extension Line (U2 Total Knee SystemPSA Type) · United Orthopedic Corporation510(k) · 2025-09-25
Materialise TKA Guide System · Materialise NV510(k) · 2025-07-14
EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) · Encore Medical L.P.510(k) · 2025-07-08
EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) · Encore Medical L.P.510(k) · 2025-07-02
Freedom® Total Knee System Titanium Tibial Base Plate · Maxx Orthopedics, Inc.510(k) · 2025-06-26
NextStep Arthropedix Total Knee System · Nextstep Arthropedix510(k) · 2025-05-08
EXULT Knee Replacement System · Corentec Co., Ltd.510(k) · 2025-04-17
LEGION Total Knee System · Smith & Nephew, Inc.510(k) · 2025-04-02
Klassic Knee System - Revision Tibial Baseplate · Total Joint Othopedics, Inc.510(k) · 2025-03-24
Freedom Total Knee System (All-poly Tibial Plate) · Maxx Orthopedics, Inc.510(k) · 2025-03-13
Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) · Zimmer, Inc.510(k) · 2025-03-06
MedalOne Total Knee System · Suzhou Microport Orthorecon Co., Ltd.510(k) · 2025-02-28
Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique · Microport Orthopedics, Inc.510(k) · 2025-02-18
Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert · Howmedica Osteonics Corp., Dba Stryker Orthopaedics510(k) · 2025-02-06
Consensus Knee System with TiNbN · Shalby Advanced Technologies510(k) · 2025-01-14
Initia Knee System · Kyocera Medical Technologies, Inc.510(k) · 2025-01-13
Cellbrick Knee Spacer · United Orthopedic Corporation510(k) · 2024-12-20
Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System · Howmedica Osteonics Corp., Dba Stryker Orthopaedics510(k) · 2024-12-04
Freedom® Medial Congruent Liner · Maxx Orthopedics, Inc.510(k) · 2024-11-19
BKS Revision System · Ortho Development Corp.510(k) · 2024-10-25
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.